Clinical trial NCT05607927: PE-Bacon for Late Complications of Chronic Radiation-induced Rectal Injury
Official title: Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation-induced Rectal Injury: A Prospective, Multicenter, Randomized Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Radiation Injury
Keywords: PE-Bacon
Parks
complication
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.

Previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. The investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.

Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.

Detailed description: Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Compared with diversion surgery, resection surgery removes the damaged tissue completely to avoid the risks of recurrence and improve patients' outcome. Hence, resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.

With the advances of surgical techniques and perioperative care, the morbidity and mortality of resection surgery has been decreased significantly. In addition, previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. And the investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.

Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.

Eligibility criteria: Inclusion Criteria:

* 1. Patients aged 18-70 years;
* 2. Patients with Eastern Cooperative Oncology Group (ECOG) physical condition score of 0-2;
* 3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
* 4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
* 5. Patients without recurrence or metastasis of primary tumor;
* 6. The late complications of CRII patients, such as deep rectal ulcer (VRS score \>=3), rectal sigmoid colon stenosis, obstruction, chronic perforation, rectal necrosis, rectovaginal fistula, intractable anal pain caused by rectal lesions, intractable rectal bleeding which is still difficult to be relieved by stoma operation, and patients who need sigmoid colorectal resection;
* 7. Patients who can tolerate general anesthesia;
* 8. The subjects and their families are able to understand the study plan, willing to participate and sign the informed consent.

Exclusion Criteria:

* 1. Patients with acute intestinal obstruction, acute intestinal perforation and intestinal hemorrhage who need emergency operation;
* 2. Patients with severe pelvic adhesion and frozen pelvis;
* 3. Patients with unstable primary tumor or tumor in other parts;
* 4. Patients who need to undergo combined organ resection;
* 5. Patients with a history of sigmoidostomy;
* 6. American society of anesthesiologists (ASA) level IV to V;
* 7. Patients with serious mental illness;
* 8. Pregnant or lactating women;
* 9. Patients with serious cardiovascular disease, uncontrollable infection, or other uncontrollable combined diseases.

Primary outcomes:
measure: Ostomy reversal rate within 1 year after surgery
timeFrame: 1 year after surgery
measure: Incidence of anastomotic leakage within 6 months after surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Ostomy reversal rate within 2 years after surgery
timeFrame: 2 years after surgery
measure: Ostomy reversal rate within 3 years after surgery
timeFrame: 3 years after surgery
measure: Incidence of anastomotic leakage within 1 year after surgery
timeFrame: 1 year after surgery
measure: Incidence of anastomotic leakage within 2 years after surgery
timeFrame: 2 years after surgery
measure: Incidence of anastomotic leakage within 3 years after surgery
timeFrame: 3 years after surgery
measure: Incidence of anastomotic stricture within 6 months after surgery
timeFrame: 6 months after surgery
measure: Incidence of anastomotic stricture within 1 year after surgery
timeFrame: 1 year after surgery
measure: Incidence of anastomotic stricture within 2 years after surgery
timeFrame: 2 years after surgery
measure: Incidence of anastomotic stricture within 3 years after surgery
timeFrame: 3 years after surgery
measure: Incidence of severe intestinal dysfunction at 1 year after ostomy reversal
timeFrame: 1 year after ostomy reversal
measure: Incidence of severe intestinal dysfunction at 2 years after ostomy reversal
timeFrame: 2 years after ostomy reversal
measure: Incidence of severe intestinal dysfunction at 3 years after ostomy reversal
timeFrame: 3 years after ostomy reversal
measure: Quality of life at 1 year after ostomy reversal
timeFrame: 1 year after ostomy reversal
measure: Quality of life at 2 years after ostomy reversal
timeFrame: 2 years after ostomy reversal
measure: Quality of life at 3 years after ostomy reversal
timeFrame: 3 years after ostomy reversal
Other outcomes:
Locations:
Study officials:
References:
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