Protocol: Reconstruct the Pelvic Peritoneum Using BPF

NCT04177407 | Unknown DMC

• 1 other identifier: MC-SA-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Extralevator abdominoperineal excision (ELAPE) may cause various surgical complications including disruption of perineal wound, perineal hernia and adhesive small-bowel obstruction. Pelvic peritoneum reconstruction could prevent those complications, but it may not always be achievable, especially in patients with severe pelvic fibrosis after neoadjuvant radiotherapy. Previous study has reported the application of the pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. The aim of the study is to evaluate the short-term clinical, technical and safety outcomes of pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. Methods/Design: This is a single -center prospective cohort study and fulfill the IDEAL 2A stage principle. Rectal cancer patients after neoadjuvant radiotherapy and about to undergo laparoscopic ELAPE will be included. Main exclusion criteria are being complicated with urgent complications, ASA grade \> 3 and accompanied with mental illness. Patients suffering rigid pelvis or huge perineal peritoneum defect, and having difficulty in primary perineal wound closure will be considered eligible for the baldder peritoneum flap (BPF) group; corresponding rectal cancer patients will be allocated to the control group. After informed consent, 10 patients are planned to be included in the BPF group. Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using BPF are to be performed. The surgical safety is to be evaluated after one-year follow-up. Primary endpoints are the occurrence of intraoperative and postoperative complications of pelvic peritoneum reconstruction after ELAPE. Second endpoints are overall complication rate within 30 days after surgery, extent of small intestine falling down to pelvic cavity, and other follow-up consequences within 1 year after surgery.

Conditions

Rectal Cancer

Keywords

Extralevator abdominoperineal excision

Outcome Measures

Primary Outcomes (4)

• intraoperative complications

  Bleeding, flap devitalization, flap laceration, bladder injury and any other event that may cause the failure of the novel method

  within 1 week after surgery.

• postoperative complications

  Perineal wound complications and ASBO within 1 year after surgery

  3 month after surgery

• postoperative complications

  Perineal wound complications and ASBO within 1 year after surgery

  6 month after surgery

• postoperative complications

  Perineal wound complications and ASBO within 1 year after surgery

  12 month after surgery

Secondary Outcomes (1)

• Overall complication rate within 30 days after surgery.

  30 days after surgery

Study Arms (2)

BPF group

EXPERIMENTAL

Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.

Procedure: Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.

control group

NO INTERVENTION

Regarding to the pelvic peritoneum reconstruction, in control group, the pelvic peritoneum will be closed with running suturing. If not possible, the peritoneum covering the surface of the bladder will be secured on the anterior surface of the sacrum with nonabsorbable sutures at the level where the anatomic structure obliterates the pelvic entrance. If neither method was feasible, the pelvic peritoneum defect will be left unclosed.

Interventions

Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed. PROCEDURE

Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.

BPF group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged between 18 to 75.
• ASA grade ≤ 3.
• Pathology confirmed as rectal adenocarcinoma;
• Lower rectal cancer with neoadjuvant (chemo)radiotherapy, and an APR was needed;
• The pelvic peritoneum can't be close by direct suture;
• Patients being able to understand the study protocol and willing to participate in the study, providing written informed consent.

You may not qualify if:

• Bladder invaded by tumor or primary bladder cancer.
• severe systemic diseases abibuffecting wound healing (e.g. diabetes, liver cirrhosis or immune compromised status like HIV)
• Sensitivity to anti-adhesion barrier.
• Peritoneal implantation.
• History of severe mental illness.
• Continuous systemic steroid therapy recent 1 month

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (8)

• Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489.

  PMID: 17143848 BACKGROUND

• Yang T, Wei M, Deng X, Meng W, Wang Z. A Novel Laparoscopic Technique With a Bladder Peritoneum Flap Closure for Pelvic Cavity for Patients With Rigid Pelvic Peritoneum After Neoadjuvant Radiotherapy in Laparoscopic Extralevator Abdominoperineal Excision. Dis Colon Rectum. 2019 Sep;62(9):1136-1140. doi: 10.1097/DCR.0000000000001435.

  PMID: 31318767 BACKGROUND

• Aggarwal N, Seshadri RA, Arvind A, Jayanand SB. Perineal Wound Complications Following Extralevator Abdominoperineal Excision: Experience of a Regional Cancer Center. Indian J Surg Oncol. 2018 Jun;9(2):211-214. doi: 10.1007/s13193-018-0741-y. Epub 2018 Apr 14.

  PMID: 29887703 BACKGROUND

• Butt HZ, Salem MK, Vijaynagar B, Chaudhri S, Singh B. Perineal reconstruction after extra-levator abdominoperineal excision (eLAPE): a systematic review. Int J Colorectal Dis. 2013 Nov;28(11):1459-68. doi: 10.1007/s00384-013-1660-6. Epub 2013 Feb 26.

  PMID: 23440362 BACKGROUND

• McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL Group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012. doi: 10.1136/bmj.f3012.

  PMID: 23778427 BACKGROUND

• Bengtsson S, Hambraeus A, Laurell G. Wound infections after surgery in a modern operating suite: clinical, bacteriological and epidemiological findings. J Hyg (Lond). 1979 Aug;83(1):41-57. doi: 10.1017/s002217240002581x.

  PMID: 379212 BACKGROUND

• Christensen HK, Nerstrom P, Tei T, Laurberg S. Perineal repair after extralevator abdominoperineal excision for low rectal cancer. Dis Colon Rectum. 2011 Jun;54(6):711-7. doi: 10.1007/DCR.0b013e3182163c89.

  PMID: 21552056 BACKGROUND

• Shen Y, Yang T, Deng X, Yang J, Meng W, Wang Z. Pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic extralevator abdominoperineal excision: A multi-center, prospective single-arm cohort study (IDEAL Phase 2A). Medicine (Baltimore). 2020 Jun 19;99(25):e20712. doi: 10.1097/MD.0000000000020712.

  PMID: 32569206 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ziqiang Wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Shen

CONTACT

17606441760; hi_moke@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastrointestinal Surgery

Model Details: This is a single-center prospective cohort study and fulfill the IDEAL 2A stage principle. Rectal cancer patients undergoing laparoscopic ELAPE, suffering rigid pelvis or huge perineal peritoneum defect, and having difficulty in primary perineal wound closure will be considered eligible. Main exclusion criteria are being complicated with urgent complications, ASA grade \> 3 and accompanied with mental illness. Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: March 23, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)