STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
NCT ID: NCT05352074
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
252 participants
INTERVENTIONAL
2022-03-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total colectomy with ileorectal anastomosis
Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation.
Total colectomy with ileorectal anastomosis
Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.
Subtotal colectomy with cecal-rectal anastomosis
Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation.
Subtotal colectomy with cecal-rectal anastomosis
Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.
Interventions
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Total colectomy with ileorectal anastomosis
Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.
Subtotal colectomy with cecal-rectal anastomosis
Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.
Eligibility Criteria
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Inclusion Criteria
2. Patients with conditions in agreement with the Roman IV criteria of functional constipation
3. Patients have less than one complete spontaneous bowel movement per week
4. Patients rely on laxatives to assist defecation for a long time
5. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
6. Patients were refractory to conservative treatment for more than 1 year
7. Patients with a strong desire for surgery
Exclusion Criteria
2. Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
3. Patients with colorectal neoplasms
4. Patients with small intestinal slow transit
5. Patients with constipation-predominant irritable bowel syndrome
6. Patients with inflammatory bowel disease
7. Patients with ileostomy
8. Patients with severe psychiatric disease
18 Years
80 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Weidong Tong
Director
Principal Investigators
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Weidong Tong, MD
Role: STUDY_DIRECTOR
Army Medical Center (Daping Hospital)
Locations
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Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China
No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
Lanzhou, Gansu, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shengyang, Liaoning, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China
Shanghai Pudong New Area People's Hospital
Pudong, Shanghai Municipality, China
Xijing Hospital
Xi’an, Shanxi, China
Chengdu Analrectal Hospital
Chengdu, Sichuan, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.
Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
Perivoliotis K, Baloyiannis I, Tzovaras G. Cecorectal (CRA) versus ileorectal (IRA) anastomosis after colectomy for slow transit constipation (STC): a meta-analysis. Int J Colorectal Dis. 2022 Mar;37(3):531-539. doi: 10.1007/s00384-022-04093-y. Epub 2022 Jan 12.
Knowles CH, Grossi U, Horrocks EJ, Pares D, Vollebregt PF, Chapman M, Brown S, Mercer-Jones M, Williams AB, Yiannakou Y, Hooper RJ, Stevens N, Mason J; NIHR CapaCiTY working group; Pelvic floor Society and; European Society of Coloproctology. Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations. Colorectal Dis. 2017 Sep;19 Suppl 3:101-113. doi: 10.1111/codi.13775.
Deng XM, Zhu TY, Wang GJ, Gao BL, Li RX, Wang JT. Laparoscopic total colectomy with ileorectal anastomosis and subtotal colectomy with antiperistaltic cecorectal anastomosis for slow transit constipation. Updates Surg. 2023 Jun;75(4):871-880. doi: 10.1007/s13304-023-01458-y. Epub 2023 Mar 14.
Tian Y, Guo M, Bu F, Ni L, Liu W, Gao F, Lan H, Cui Z, Fu T, Wang Y, Li F, Xu D, Gao H, Zhang L, Liu X, Huang B, Wang L, Jiang C, Jiang J, Gong W, Tong W. Total colectomy with ileorectal anastomosis versus subtotal colectomy with cecal-rectal anastomosis for slow transit constipation: protocol for a multicenter randomized controlled trial (STOPS trial). Trials. 2025 Oct 10;26(1):402. doi: 10.1186/s13063-025-09049-5.
Other Identifiers
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20211114
Identifier Type: -
Identifier Source: org_study_id
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