OBJECTIVE: To evaluate the long-term oncological and functional outcomes of re-adaptation of the dorsolateral peritoneal layer after pelvic lymph node dissection (PLND) and cystectomy. PATIENTS AND METHODS: A randomized, single-centre, single-blinded, two-arm trial was conducted on 200 consecutive patients who underwent PLND and cystectomy for bladder cancer (<cT4, cN0, cM0) between April 2006 and September 2009. Patients were randomized into two groups: group A with re-adaptation of the dorsolateral peritoneal layer (n = 100; 73 male, 27 female; median [range] age 68 [35-86] years) and group B without re-adapation (n = 100; 66 male, 34 female; median [range] age 65 [30-86] years). Regular postoperative follow-up was performed at our outpatient clinic. The median follow-up was 59 (3-100) months. Five patients were lost to follow-up in group A and seven in group B. Bowel function was evaluated using the validated Gastrointestinal Quality of Life Index questionnaire and an institutional questionnaire regarding post-cystectomy outcome. Local recurrences and distal metastases were evaluated using computed tomography and bone scan at the regular follow-up visits. RESULTS: There was no significant difference between the two groups in terms of the rate of local (pelvic) recurrence (5/95 [5.3%] in group A; 7/93 [7.5%] in group B; P = 0.53), the rate of distant metastases (21/95 [22.1%] in group A; 23/93 [24.7%] in group B; P = 0.67), cancer-specific survival (P = 0.37) or overall survival (P = 0.59). Group A had significantly better bowel function at 3 (P < 0.001), 6 (P < 0.006), 12 (P < 0.006) and 24 months (P = 0.04), and significantly less postoperative abdominal pain and bloating at 3 (P = 0.002) and 6 months (P = 0.01). CONCLUSION: Re-adaptation of the dorsolateral peritoneal layer after PLND and cystectomy has a beneficial long-term impact on bowel function and postoperative pain without compromising oncological radicality.
RCT Entities:
OBJECTIVE: To evaluate the long-term oncological and functional outcomes of re-adaptation of the dorsolateral peritoneal layer after pelvic lymph node dissection (PLND) and cystectomy. PATIENTS AND METHODS: A randomized, single-centre, single-blinded, two-arm trial was conducted on 200 consecutive patients who underwent PLND and cystectomy for bladder cancer (<cT4, cN0, cM0) between April 2006 and September 2009. Patients were randomized into two groups: group A with re-adaptation of the dorsolateral peritoneal layer (n = 100; 73 male, 27 female; median [range] age 68 [35-86] years) and group B without re-adapation (n = 100; 66 male, 34 female; median [range] age 65 [30-86] years). Regular postoperative follow-up was performed at our outpatient clinic. The median follow-up was 59 (3-100) months. Five patients were lost to follow-up in group A and seven in group B. Bowel function was evaluated using the validated Gastrointestinal Quality of Life Index questionnaire and an institutional questionnaire regarding post-cystectomy outcome. Local recurrences and distal metastases were evaluated using computed tomography and bone scan at the regular follow-up visits. RESULTS: There was no significant difference between the two groups in terms of the rate of local (pelvic) recurrence (5/95 [5.3%] in group A; 7/93 [7.5%] in group B; P = 0.53), the rate of distant metastases (21/95 [22.1%] in group A; 23/93 [24.7%] in group B; P = 0.67), cancer-specific survival (P = 0.37) or overall survival (P = 0.59). Group A had significantly better bowel function at 3 (P < 0.001), 6 (P < 0.006), 12 (P < 0.006) and 24 months (P = 0.04), and significantly less postoperative abdominal pain and bloating at 3 (P = 0.002) and 6 months (P = 0.01). CONCLUSION: Re-adaptation of the dorsolateral peritoneal layer after PLND and cystectomy has a beneficial long-term impact on bowel function and postoperative pain without compromising oncological radicality.