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10.1245/s10434-007-9355-2
Annals of Surgical Oncology 14:1972-1979 (2007)
© 2007 Society of Surgical Oncology
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Original Article

Comparison of Functional and Surgical Outcomes of Laparoscopic-Assisted Colonic J-Pouch Versus Straight Reconstruction After Total Mesorectal Excision for Lower Rectal Cancer

Jin-Tung Liang, MD, PhD1, Hong-Shiee Lai, MD, PhD1, Po-Huang Lee, MD, PhD1 and Kuo-Chin Huang, MD, PhD2

1 Department of Surgery, National Taiwan University Hospital and College of Medicine, No. 7, Chung-Shan South Road, Taipei, Taiwan, Republic of China
2 Department of Family Medicine, National Taiwan University Hospital and College of Medicine, No. 7, Chung-Shan South Road, Taipei, Taiwan, Republic of China

Correspondence: Address correspondence and reprint requests to: Jin-Tung Liang, MD, PhD; E-mail: jintung{at}ntu.edu.tw


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Background: To compare the functional and surgical outcomes of colonic J-pouch and straight anastomosis in the context that both reconstruction procedures were performed laparoscopically.

Methods: The present study was a randomized prospective clinical trial. Patients with lower rectal cancer requiring laparoscopic total mesorectal excision were equally randomized to either laparoscopic-assisted colonic J-pouch reconstruction or laparoscopic straight end-to-end anastomosis. The techniques of the laparoscopic-assisted colonic J-pouch reconstruction are shown in the attached video. The primary end point was the comparison of functional results in both reconstruction methods. The secondary end points included the safety (surgical morbidity and mortality), surgical efficiency, and postoperative recovery.

Results: A total of 48 patients were recruited within 2-year periods, in consideration of statistical power of 90% for comparison. There was no marked difference between patient groups undergoing colonic J-pouch surgery (n = 24) and straight anastomosis (n = 24) in various demographic and clinicopathogic parameters. The anorectal function of patients by colonic J-pouch were better than those by straight anastomosis in 3 months after operation, as evaluated by stool frequency (mean ± standard deviation: 4.0 ± 2.0 vs. 7.0 ± 2.4 times/day, P < .001); use of antidiarrheal agents (29.2% [n = 7] vs. 75.0% [n = 18], P = .004); and perineal irritation (45.8% [n = 11] vs. 79.2% [n = 19], P = .037). Because of the relatively better bowel function in immediate postoperative period, patients by colonic J-pouch reconstruction were less disabled after surgery and had quicker return to partial activity (P = .039), full activity (P < .001), and work (P < .001). Both reconstruction methods were performed with similar amounts of blood loss, complication rates, and postoperative recovery. However, the operation time was significantly longer in the colonic J-pouch group (274.4 ± 34.0 vs. 202.0 ± 28.0 minutes, P < .001).

Conclusions: Because laparoscopic-assisted creation of a colonic J-pouch achieved better short-term functional results of the anorectum and did not increase surgical morbidity, as compared with laparoscopic straight anastomosis, this reconstruction procedure could be recommended to patients with lower rectal cancer requiring laparoscopic total mesorectal excision.

Key Words: Laparoscopic surgery • Colonic J-pouch • Rectal cancer • Total mesorectal excision


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Surgical treatment of rectal cancer seeks to find a balance between radical excision of the tumor and preservation of defecation and genitourinary function. Total mesorectal excision, which involves the precise excision of the entire rectum and pararectal lymph nodes en bloc, can achieve adequate oncologic clearance with low local recurrence rate of 3%–6%.1 On the other hand, with the introduction of circular stapling devices, restoration of bowel continuity is possible most of the time, without compromise of oncologic clearance. However, traditional end-to-end (straight) anastomosis at the level of the anorectal junction results in compromised bowel function. After a total mesorectal excision, the compliant rectum that has been removed is reconstructed by a less compliant segment of colon, which is physiologically less suitable for storing and regulating feces. The clinical manifestations for such patients include excessive stool frequency, urgency, and varying degrees of fecal incontinence. To overcome such anorectal functional disorders, Lazorthes et al.2 first advocated the colonic J-pouch procedures. Although research has shown that the colonic J-pouch reconstruction method was superior to straight anastomosis in postoperative function of anorectum, the conclusions were drawn on the basis of both reconstruction methods were performed by traditional open surgery.3–14 Yet more and more procedures of total mesorectal excision for the radical extirpation of middle and lower rectal cancers are being performed by a laparoscopic approach.15,16 Therefore, we conducted this study to evaluate whether the prevailing functional benefits of the colonic J-pouch procedure over traditional end-to-end straight reconstruction, as shown in traditional open surgery, can be reproduced when both reconstruction procedures were performed laparoscopically.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Patient Selection and Randomization
We conducted this prospective randomized trial to compare the functional and surgical outcomes of colonic J-pouch and straight end-to-end anastomosis for the reconstruction of patients with middle or low rectal cancer after total mesorectal excision. The study population comprised patients who were willing to undergo both reconstruction methods laparoscopically. Patients were well informed regarding the details of both reconstruction methods, the potential advantages and disadvantages, and the possible complications. Informed consent was obtained from all patients. This study was approved by the Institutional Ethics Committee of National Taiwan University Hospital. The primary end point was the anorectal functional outcomes in both reconstruction methods. The secondary end points were safety, surgical efficiency, and complications. We hypothesized that the colonic J-pouch procedure was better in postoperative anorectal function than straight anastomosis, even when both methods were performed laparoscopically.

Before entry onto the study, patients had to meet certain inclusion and exclusion criteria. The inclusion criteria were: (1) curative and elective surgery; (2) rectal adenocarcinoma below the peritoneal reflection and sphincter preservation was possible; and (3) American Society of Anesthesiology (ASA) function class I–III. The exclusion criteria were: (1) emergency or urgent surgery; (2) cancer located at upper rectum (above the peritoneal reflection), or very low-lying rectal cancer requiring an abdominal-perineal resection; (3) evidence of invasion of adjacent organs or distant metastasis; (4) previous major abdominal or pelvic surgery; (5) anal incontinence before surgery; (6) body mass index (BMI) ≥35 kg/m2; and (7) previous chemoradiotherapy.

The estimation of sample size was based on our preliminary data that the 3-month bowel frequency (mean ± standard deviation) in J-pouch and straight methods was 4.0 ± 2.0 and 6.0 ± 2.0 respectively, when both procedures were performed by traditional open surgery. A sample size of 23 in each group will have 90% power to detect a difference in means of 2.0 (the difference between a group 1 mean of 4.0 and a group 2 mean of 6.0), assuming that the common standard deviation is 2.0 by a two-group t-test with a .050 two-sided significance level. Patients were assigned to either the colonic J-pouch or the straight anastomosis group by means of sealed opaque envelopes containing computer-generated random numbers. To prevent selection bias, random numbers were generated by an investigator who was not involved in enrollment of patients. Patients were randomized in the operating room right before surgery.

Operative Techniques
The surgical techniques of laparoscopic-assisted end-to-end straight anastomosis have been described in our previous multimedia article.16 The details of the laparoscopic-assisted colonic J-pouch reconstruction are shown in the video attached to the present article. Briefly, complete mobilization of left-sided colon is performed to the level of the middle colic vessels by laparoscopic medial-to-lateral dissection technique, as we showed in our previous article.17 After ligation of the inferior mesenteric vessel proximal to the left colic vessels, the dissection was shifted to the mobilization of rectum. After total mesorectal excision, the rectum was clamped and transected at least 2 cm distal to the distal edge of the tumor, the bowel was then exteriorized, and the proximal colon was divided with a linear cutting stapler. The level of this transection must allow a well-vascularized segment of descending (preferably) or sigmoid (rarely) colon for anastomosis.18 An 8-cm colonic J-pouch was made by folding the colon and creating a side-to-side anastomosis with two linear cutting staplers (45 x 3.5 mm, Tyco) introduced through the apex of the pouch. Last, a stapled colo-anal anastomosis was performed.

Functional Assessment
The anorectal function was evaluated by questionnaire-based interview of patients preoperatively and then 3 and 6 months after surgery. The preoperative functional questionnaire was based on the recollection of function before the development of symptoms from the rectal cancer. Those with a defunctioning colostomy were evaluated 3 and 6 months after stoma reversal. Functional questionnaires regarding fecal continence and bowel function were completed by an assistant who was not aware of the randomization status of the patient. Continence was recorded as grade 1 (perfect continence), grade 2 (incontinence of flatus), grade 3 (occasional minor soiling), grade 4 (frequent major soiling), and grade 5 (total incontinence).19 Urgency was recorded in patients who did not have the ability to defer defecation for more than 15 minutes. Furthermore, episode and frequency of fecal leakage and the need of pad were recorded. Questions concerning bowel function included daily stool frequency, use of antidiarrheal agent or laxatives, presence of incomplete defecation and/or fragmentation, and need of enema or digital evacuation of stool. Fragmentation of stools was defined as the inability to defecate and empty the reservoir in one attempt. Fragmented stools were counted as multiple bowel movements.

Anorectal Manometry and Volumetric Study
The data of anorectal manometry and volumetric study were validated by the comparison with those of a control group, which were available in our colo-rectal physiology laboratory. The assessment was performed twice in 3 and 6 months, respectively, after one-stage tumor excision or final colostomy reversal surgery. Anal resting and squeeze pressures were measured by an open, water-perfused catheter connected by a transducer to a recorder (Albyn Medical, Griffon, United Kingdom). Pressure profile was measured by manual pull-through of the catheter at 1-cm intervals. A catheter with a latex balloon was inserted through the anal canal and above the anastomosis, and the balloon was filled with water in increments of 20 mL. Threshold volume was defined as the infused volume that made patients first aware of the presence of the balloon. Maximum tolerable volume was defined as the volume at which the patient could not tolerate further infusion.20 Rectal compliance ({Delta}V/{Delta}P) was measured by changes in volume (mL) per unit of pressure (cm H2O).

Evaluation of Surgical Outcomes
We assessed the surgical efficiency by using parameters that included length of operation time (counted from the beginning of skin incision to the final skin closure), blood loss (measured by the amount of blood in suction bottle and the number of blood-soaked gauzes), conversion rate, intraoperative and postoperative complications, and wound size. The wound size was measured by summation of the length of one major wound (generally 5 cm in size) for tumor retrieval and four working ports (5–12 mm in diameter). The operative complications, if present, were individually listed.

The functional recovery was compared by length of postoperative restoration of flatus passage and hospitalization, degree of postoperative pain, and disability. The visual analog scale was used in assessing postoperative pain on the first postoperative day. A standardized questionnaire was given to patients to assess disability, which included the number of days until return to partial activity, full activity, and work; responses were subjective.21 All parameters of functional recovery were evaluated by research assistants who were blinded to the study groups.

Statistics
Data were analyzed on the basis of the intention-to-treat principle. The two-tailed Fisher exact test or {chi}2 test was used to analyze the categorical data. The continuous data were compared by the Student t-test. The significance level of all tests was set at P < .05.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Between May 2004 and April 2006, a total of 48 patients were recruited and equally allocated to the two study groups. All patients were followed up until October 2006 (median, 18 months; range, 6–30 months). The colonic J-pouch and straight anastomosis group of patients were well matched (P > .05) for age, sex, BMI, ASA functional class, tumor distance above anal verge, distal resection margin, circumferential resection margin, number of collected lymph nodes, and tumor, node, metastasis system stage (Table 1Go).


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  		TABLE 1. Demographics and clinicopathologic data between groupsa
 
Table 2Go demonstrated manometric and volumetric data of the patients. In the early postoperative period (3 months), there was no marked difference in recto-anal inhibitory reflex and pressure profile among the two study groups and the control group. This implied that the sphincteric function remained intact after the two surgical procedures. On the other hand, although the threshold volume, maximal tolerable volume, and rectal compliance were considerably reduced after both colonic J-pouch reconstruction and straight anastomosis, they were significantly lower (P < .001) in patients with straight anastomosis than in those with J-pouch. The manometric and volumetric data of both group improved very little in the repeated evaluation performed 6 months after surgery.


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  		TABLE 2. Anorectal manometry and volumetric test between groupsa
 
Functional results are listed in Table 3Go. There was no significant difference (P > .05) between colonic J-pouch and straight anastomosis groups of patients in continence grading and feces/flatus differentiation. Likewise, there was no statistically significant difference between the groups in urgency. With regard to bowel function, we found that a considerable percentage of patients in both groups experienced increased stool frequency, incomplete defecation, and fragmentation postoperatively, but only the degree of the bowel frequency was significantly lower (P < .001) in patients with colonic J-pouch reconstruction than those with straight anastomosis. The derangement of bowel movement frequently resulted in perineal irritation and the necessity of antidiarrheal medication, as demonstrated by the degree of perineal irritation (P = .037) and antidiarrheal medication (P = .004), which were significantly lower in J-pouch group than in straight anastomosis group. Although the rate of incomplete defecation and fragmentation stool was lower in J-pouch than in straight anastomosis group, it did not reach statistical significance (P > .05). Additionally, it was noted that the construction of a relatively large pouch (up to 8 cm in size) did not increase the incidence of incomplete stool evacuation, as the use of laxative and digital evacuation of stool were very infrequently seen in both groups of patients. Again, we found that the bowel derangement seen at 3-month time point improved very little at a 6-month reevaluation.


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  		TABLE 3. Functional assessment between groups
 
The comparison of various parameters of surgical outcomes between J-pouch and straight anastomosis groups of patients is shown in Table 4Go. Construction of the colonic J-pouch tended to take more time than the straight anastomosis (P < .001). There was no significant difference (P > .05) between the two groups in blood loss, wound size, restoration of flatus passage, hospitalization, postoperative pain, and postoperative complications. There was no anastomotic leakage in both groups. However, 4 patients (16.7%) in the J-pouch group and 3 patients (12.5%) in the straight anastomosis group were protected by a diverting ileostomy. Because of the better postoperative bowel function, the patients in the J-pouch group had less disability, as shown by the quicker return to partial activity (P = .039), full activity (P < .001), and work (P < .001). Additionally, it was found that colonic J-pouch facilitated the use of a bigger size of CEEA stapler (Premium Plus CEEA, Autosuture, Tyco).


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  		TABLE 4. Parameters related to the surgical outcomes between groups
 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
The present randomized prospective controlled clinical trial demonstrated that colonic J-pouch reconstruction provided better short-term functional results than the conventional straight anastomosis without adding surgical complications; both procedures were performed laparoscopically. It has been generally accepted that a surgical trial is quite different from a medical trial in essence. The techniques and pitfalls for the conduction of a randomized prospective clinical trial regarding the laparoscopic resection of colorectal cancer have been addressed in our previous articles.22 Compared with the previous randomized trials in the literature,21,22 the present study has the following strengths. First, because both J-pouch and straight reconstruction methods were widely used by the colorectal surgeons in traditional open surgery and the patients usually did not have any idea regarding the details of surgical procedures (i.e., the adoption of a reconstruction method was at the discretion of surgeons and included in the informed consent of our daily routine practice for lower rectal cancer), the ethical issues commonly involved in the randomized clinical trials could be circumvented, and therefore, it was relatively easy to recruit enough patients for study. Second, the evaluation of functional outcomes, including clinical symptoms and the manometric and volumetric data of patients, would be vulnerable to a subjective placebo effect if the clinical trial lacked blinding between patients and assessors. In the present study, the abdominal wounds were the same between the two study groups, and therefore, the functional parameters were evaluated in a double-blind manner, because the patients and assessors were both ignorant of the surgical procedure that had been performed.

In this study, we showed that a colonic J-pouch procedure is more time-consuming than straight anastomosis. This could be explained by the simple fact that shaping an additional colonic J-pouch is more complex than doing traditional straight end-to-end anastomosis. However, we thought that colonic J-pouch reconstruction was also technically more difficult than the end-to-end anastomosis, especially when both procedures were performed laparoscopically. First, the colonic J-pouch reconstruction needs more extensive dissection to completely take down the colonic splenic flexure, thus facilitating the construction of a J-pouch at descending (preferably) or sigmoid colon and ensuring the followed tension-free J-pouch–anal anastomosis.18 Second, in comparison with straight anastomosis, the colonic J-pouch was relatively bulky; this might hinder a precise J-pouch–anal stapling anastomosis, particularly in the male narrow pelvis or when the patient was fatty. Third, during the fashioning of a colonic J-pouch, the patient underwent an additional staple to open the septum of the folded colon. This additional 8-cm stapling line might theoretically increase the rate of anastomotic leakage. There was no anastomotic leak in the present study population. This may be because of our efforts to fully mobilize the left-sided colon, thus ensuring a tension-free pouch-anal anastomosis, and because, most importantly, the J-pouch–anal anastomosis was protected by a defunctioning ileostomy in a subset of patients (14.6%, n = 7) who had comorbid factors, poor nutritional status, edematous bowel, and/or technical insecurity of stapling.23

The better anorectal function of a colonic J-pouch was generally considered to be due to the relatively large capacity and reversed peristalsis in the neorectal reservoir.3–14 The volumetric data in the present study supported the concept of larger capacity and compliance in J-pouch neorectum. Some researchers stress the importance of the antiperistaltic character of a colonic J-pouch and advocate that a small J-pouch (5 cm in size) can achieve similar bowel function and simultaneously prevent the potential incomplete evacuation of stool from a large J-pouch (8 cm).24–28 In the present study, we did not find any increased rate of incomplete evacuation of stool in the J-pouch group of patients. Remarkably, the comparison of functional outcomes between the small and large colonic J-pouches was inconsistent in the literature.3–14,24–28 Furthermore, the present study showed that the bowel continuity of patients in colonic J-pouch group tends to be reconstructed by the bigger size of CEEA stapler, as compared with that of patients in the straight anastomosis group. Although there was no anastomotic stricture in the present colonic J-pouch and straight anastomosis groups of patients, it was conceivable that the bigger coloanal anastomotic ring would have a positive effect on the postoperative anorectal function. To further explore the underlying mechanisms for the better anorectal function of the patients in the colonic J-pouch group, continuous long-term follow-up of the present study population will be necessary.


   ACKNOWLEDGMENTS
 
Supported by a grant from National Taiwan University Hospital (96-S557).


   FOOTNOTES
 
Electronic supplementary material: The online version of this article (doi:10.1245/s10434-007-9355-2) contains supplementary material, which is available to authorized users.

Received for publication June 2, 2006. Accepted for publication December 26, 2006.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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