title: Long-term results of a prospective randomized trial assessing the impact of re-adaptation of the dorsolateral peritoneal layer after extended pelvic lymph node dissection and cystectomy.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.|Department of Cell and Molecular Biology, University of Medicine and Pharmacy, Targu Mures, Romania.
authors.forename: Mihai Dorin
authors.initials: MD
authors.lastname: Vartolomei
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Kiss
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Vidal
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Fiona
authors.initials: F
authors.lastname: Burkhard
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: George N
authors.initials: GN
authors.lastname: Thalmann
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Beat
authors.initials: B
authors.lastname: Roth
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015653:Cystectomy / Q000379:methods* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology / Q000401:mortality; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010388:Pelvis; D010537:Peritoneum / Q000601:surgery; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011300:Preoperative Care; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D013524:Surgical Flaps; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000601:surgery*; D014547:Urinary Diversion / Q000379:methods
keywords: bowel function; cystectomy; long-term outcomes; pelvic lymph node dissection; prospective randomized trial