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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parks surgery group | Other | The CRII patients received Parks surgery |
|
| PE-Bacon surgery group | Experimental | The CRII patients received PE-Bacon surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parks surgery | Procedure | Parks surgery |
| |
| PE-Bacon surgery |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tenghui Ma, PhD | Contact | 13560232462 | matengh@mail.sysu.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16080176 | Background | 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. | |
| 17976611 | Background | 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. |
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| Procedure |
PE-Bacon 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 |
| 22046090 | Background | 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. |
| 28429071 | Background | 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. |
| 28153025 | Background | 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. |
| 10436361 | Background | Meissner K. Late radiogenic small bowel damage: guidelines for the general surgeon. Dig Surg. 1999;16(3):169-74. doi: 10.1159/000018721. |
| 30976422 | Background | 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. |
| 35548188 | Background | 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. |
| 7305485 | Background | 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. |
| 3946764 | Background | 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. |