Protocol: Reconstruct the Pelvic Peritoneum Using BPF (PPRBPF)

May 11, 2020 updated by: Ziqiang Wang,MD, West China Hospital

Pelvic Peritoneum Reconstruction Using the Bladder Peritoneum Flap in Laparoscopic Extralevator Abdominoperineal Excision --- A Multi-center, Prospective Single-Arm Cohort Study (IDEAL Phase 2A)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In rectal cancers, the overall survival will benefit strongly if a negative incisional margin is reached. In order to pursue a negative margin, APR, expecially the extralevator abdominoperineal excision (ELAPE) which introduced by Holm et al had been used to improve the oncological outcome in T3 and T4 rectal cancer. However, ELAPE could bring a gaping hole beyond repair in the pelvic cavity, leading to serious perineal injury and small bowel dropping into pelvic cavity inevitably. Pelvic peritoneal defects can also result in perineal hernia and adhesive small-bowel obstruction (ASBO).

Reconstruction the pelvic peritoneum could prevent the small intestine adhering to the true pelvis by keeping it in the abdominal cavity, thus decrease the occurrence of ASBO and other perineal complications. However, pelvic peritoneum reconstruction may not always be feasible especially in those patients who had received a neoadjuvant radiotherapy and suffered severe tissue fibrosis or those patients who have a large defect of pelvic peritoneum.

Recently the investigators have reported a novel method to reconstruct the pelvic peritoneum under laparoscope in patients with a rigid pelvis. A bladder peritoneum flap was used to cover the defect of pelvic peritoneum. Previous attempts have proved the feasibility of the pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. This protocol is a further study to verify its short-term clinical, technical and safety outcomes.

The objective of this study is to evaluate the short-term clinical, technical and safety outcomes of pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE.

This is a multi-center, prospective development study. The method of PPR using the bladder peritoneum flap in laparoscopic ELAPE is at the development stage. And this protocol fulfills the requirement of IDEAL framework stage 2A. Approval of the ethics committee has been obtained from the ethics committee of West China Hospital, Sichuan University (2019 No. 194). The present study was registered on the clinicaltrials.gov. Any technology amendments will be presented to the institutional review board for further assessment. Benefits and risks of the study will be informed to participants. Only participants who signed an informed consent form and agree to participate will be included in this study. Participants have the right to quit the study at any time without any reason. In emergency circumstances, surgeons have the right to end the study. Data of the details will be stored in a database and published after the trial.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPF group
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.
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative complications
Time Frame: within 1 week after surgery.
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
Time Frame: 3 month after surgery
Perineal wound complications and ASBO within 1 year after surgery
3 month after surgery
postoperative complications
Time Frame: 6 month after surgery
Perineal wound complications and ASBO within 1 year after surgery
6 month after surgery
postoperative complications
Time Frame: 12 month after surgery
Perineal wound complications and ASBO within 1 year after surgery
12 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complication rate within 30 days after surgery.
Time Frame: 30 days after surgery
Overall complication rate within 30 days after surgery.
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Ziqiang Wang, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 23, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-SA-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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