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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
Author(s) -
Vartolomei Mihai Dorin,
Kiss Bernhard,
Vidal Alvaro,
Burkhard Fiona,
Thalmann George N.,
Roth Beat
Publication year - 2016
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.13178
Subject(s) - medicine , cystectomy , randomized controlled trial , lymph node , dissection (medical) , surgery , bladder cancer , defecation , urology , cancer
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 (< cT 4, cN 0, cM 0) 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.