PE-Bacon for Late Complications of Chronic Radiation-induced Rectal Injury (PE-Bacon)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Radiation Injury
• Intervention / Treatment: Procedure: Parks surgery; Procedure: PE-Bacon surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tenghui Ma, PhD; Phone Number: 13560232462; Email: matengh@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Parks surgery group; The CRII patients received Parks surgery	Procedure: Parks surgery; Parks surgery
Experimental: PE-Bacon surgery group; The CRII patients received PE-Bacon surgery	Procedure: PE-Bacon surgery; PE-Bacon surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ostomy reversal rate within 1 year after surgery	Ostomy reversal rate within 1 year after surgery	1 year after surgery
Incidence of anastomotic leakage within 6 months after surgery	Incidence of anastomotic leakage within 6 months after surgery	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ostomy reversal rate within 2 years after surgery	Ostomy reversal rate within 2 years after surgery	2 years after surgery
Ostomy reversal rate within 3 years after surgery	Ostomy reversal rate within 3 years after surgery	3 years after surgery
Incidence of anastomotic leakage within 1 year after surgery	Incidence of anastomotic leakage within 1 year after surgery	1 year after surgery
Incidence of anastomotic leakage within 2 years after surgery	Incidence of anastomotic leakage within 2 years after surgery	2 years after surgery
Incidence of anastomotic leakage within 3 years after surgery	Incidence of anastomotic leakage within 3 years after surgery	3 years after surgery
Incidence of anastomotic stricture within 6 months after surgery	Incidence of anastomotic stricture within 6 months after surgery	6 months after surgery
Incidence of anastomotic stricture within 1 year after surgery	Incidence of anastomotic stricture within 1 year after surgery	1 year after surgery
Incidence of anastomotic stricture within 2 years after surgery	Incidence of anastomotic stricture within 2 years after surgery	2 years after surgery
Incidence of anastomotic stricture within 3 years after surgery	Incidence of anastomotic stricture within 3 years after surgery	3 years after surgery
Incidence of severe intestinal dysfunction at 1 year after ostomy reversal	Incidence of severe intestinal dysfunction at 1 year after ostomy reversal	1 year after ostomy reversal
Incidence of severe intestinal dysfunction at 2 years after ostomy reversal	Incidence of severe intestinal dysfunction at 2 years after ostomy reversal	2 years after ostomy reversal
Incidence of severe intestinal dysfunction at 3 years after ostomy reversal	Incidence of severe intestinal dysfunction at 3 years after ostomy reversal	3 years after ostomy reversal
Quality of life at 1 year after ostomy reversal	Quality of life at 1 year after ostomy reversal	1 year after ostomy reversal
Quality of life at 2 years after ostomy reversal	Quality of life at 2 years after ostomy reversal	2 years after ostomy reversal
Quality of life at 3 years after ostomy reversal	Quality of life at 3 years after ostomy reversal	3 years after ostomy reversal

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

General Publications

• Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324. Erratum In: Cancer. 2006 Aug 1;107(3):660.
• Andreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8.
• Perrakis N, Athanassiou E, Vamvakopoulou D, Kyriazi M, Kappos H, Vamvakopoulos NC, Nomikos I. Practical approaches to effective management of intestinal radiation injury: benefit of resectional surgery. World J Gastroenterol. 2011 Sep 21;17(35):4013-6. doi: 10.3748/wjg.v17.i35.4013.
• McCrone LF, Neary PM, Larkin J, McCormick P, Mehigan B. The surgical management of radiation proctopathy. Int J Colorectal Dis. 2017 Aug;32(8):1099-1108. doi: 10.1007/s00384-017-2803-y. Epub 2017 Apr 20.
• Zhong Q, Yuan Z, Ma T, Wang H, Qin Q, Chu L, Wang J, Wang L. Restorative resection of radiation rectovaginal fistula can better relieve anorectal symptoms than colostomy only. World J Surg Oncol. 2017 Feb 2;15(1):37. doi: 10.1186/s12957-017-1100-0.
• Meissner K. Late radiogenic small bowel damage: guidelines for the general surgeon. Dig Surg. 1999;16(3):169-74. doi: 10.1159/000018721.
• Qin Q, Zhu Y, Wu P, Fan X, Huang Y, Huang B, Wang J, Wang L. Radiation-induced injury on surgical margins: a clue to anastomotic leakage after rectal-cancer resection with neoadjuvant chemoradiotherapy? Gastroenterol Rep (Oxf). 2019 Apr;7(2):98-106. doi: 10.1093/gastro/goy042. Epub 2018 Dec 11.
• He Y, Zhou Z, Huang X, Guan Q, Qin Q, Zhu M, Wang H, Zhong Q, Chen D, Wang H, Fang L, Ma T. Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation Proctopathy. Front Surg. 2022 Apr 25;9:845148. doi: 10.3389/fsurg.2022.845148. eCollection 2022.
• Anseline PF, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Radiation injury of the rectum: evaluation of surgical treatment. Ann Surg. 1981 Dec;194(6):716-24. doi: 10.1097/00000658-198112000-00010.
• Jao SW, Beart RW Jr, Gunderson LL. Surgical treatment of radiation injuries of the colon and rectum. Am J Surg. 1986 Feb;151(2):272-7. doi: 10.1016/0002-9610(86)90086-3.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2022
• Primary Completion (Anticipated): August 30, 2025
• Study Completion (Anticipated): August 30, 2028

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: complication; PE-Bacon; Parks
• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries
• Other Study ID Numbers: PE-Bacon2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No