Acute Malignant Colonic ObstructionNCT01997684
Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction
A study testing Colonic Stenting with Elective Surgery and Emergency Surgery in people with Acute Malignant Colonic Obstruction and Colorectal Cancer, run by Nanfang Hospital, Southern Medical University at 9 sites in China.
Trial summary
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality. However, the available body of literature addressing their benefit in this setting is contradictory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Malignant Colonic Obstruction, Colorectal Cancer, Colonic Obstruction
- What is being tested?
- Colonic Stenting with Elective Surgery and Emergency Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesChina
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age.
- Symptoms of colonic obstruction, existing less than one week.
- Malignant obstruction in the colon.
- Signed informed consent.
Who cannot join
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk.
- Patients with signs of peritonitis, perforation, sepsis, or other serious complications demanding emergency surgery.
- Patients with distal rectal cancer less than 8 cm from the anal verge.
- Patients with suspected or proven metastatic adenocarcinoma.
- Patients with unresectable colorectal cancer, or planning for palliative treatment.
- Previous colonic surgery.
- Pregnancy or lactation women, or ready to pregnant women.
- Not capable of filling out questionnaires.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Xiangya hospital central-south university
Changsha, Hunan, 410008
Miao Ouyang, M.D.
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fenglin Chen, M.D.
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Liping He, M.D.
- Recruiting
Guangdong Province Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Beiping Zhang, M.D.
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Hong Wang, M.D.
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Wei Gong, M.D.
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Chujun Li, M.D.
- Recruiting
Renji Hospital, Medical College of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200032
Ming Zhong, M.D.
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Siyu Sun, M.D.
About this study
Official title: Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Cohort Study
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality.
However, the available body of literature addressing their benefit in this setting is contradictory.
The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
Read the detailed description
Colorectal cancer is one commonly diagnosed malignancy worldwide, with an estimated 10 million new cases and 6 million deaths . Around 8%-29% of patients with colorectal cancer present with acute colonic obstruction, and 70% of all malignant obstruction occurs in the left-sided colon. It has been reported that about 15%-20 % of patients with colorectal cancer present with acute obstructive symptoms at the time of diagnosis.
Conventionally, these patients are treated with emergency surgery to restore luminal continuity, which includes a variety of strategies such as the so-called two-stage surgery involving primary resection with colostomy (i.e., Hartmann's procedure) or proximal colostomy followed by resection, and one-stage surgery involving primary resection with anastomosis. Whatever the strategy chosen, the emergency surgery has an associated high risk of morbidity and mortality, and about two-thirds of such patients end up with a permanent stoma, which caused lower health-related quality of life and costs associated with stoma care.
Since 1991, the colonic stenting has been applied as palliative treatment for patients with unresectable colorectal cancer. In 1993, Tejero et al. reported using colonic stenting as a bridge to definitive surgery. Recently, Zhang et al. conducted a meta-analysis of 8 studies (6 retrospective and 2 randomized trials) and indicated that stent placement before elective surgery, also known as a bridge to surgery, lead to a reduction in need of intensive care (risk ratio [RR], 0.42; 95% confidence interval, 0.19-0.93), stoma creation (RR, 0.70; 0.50-0.99), and overall complications (RR, 0.42; 0.24-0.71) compared with the emergency surgery cohort, meanwhile, colonic stenting with elective surgery achieved higher primary anastomosis rate (RR, 1.62; 1.21-2.16), and did not adversely affect the mortality and long-term survival. The most common complications of colonic stenting were re-obstruction (12%), migration (11%), and perforation (4.5%).
However, the available body of literature addressing the benefit of colonic stenting with elective surgery is contradictory, and limited by the lack of the prospective randomised controlled trials. Therefore, we plan to conduct this multicenter, prospective, open label,cohort study, to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
- Being tested
- Colonic Stenting with Elective Surgery, Emergency Surgery
- Keywords
- Colorectal Cancer, Colonic Obstruction
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic Stenting with Elective SurgeryProcedure or surgery
Also called Colonic stenting as a bridge to elective surgery, Colonic stenting and elective surgery, Colonic stenting and deferred surgery, Preoperative colonic stenting
After preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed.
If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery.
Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks.
Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
Emergency SurgeryProcedure or surgery
Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Colonic Stenting with Elective Surgery | Experimental | In the experimental group, the patients will undergo colonic stenting within 24 h of inclusion. For this study, the WallFlex ™ Colonic Stent (Boston Scientific, Natick, MA) will be employed.
Candidates for elective surgery, after clinical success of colonic stenting, will be preferably operated on 5-14 days after inclusion, and no later than 4 weeks. Type and extent of the elective surgery will be selected by the surgeon.
In this group, unplanned emergency surgery will be indicated in case of technical failure of colonic stenting, iatrogenic morbidity, or clinical failure.
In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. Receives: Procedure: Colonic Stenting with Elective Surgery |
| Emergency Surgery | Active comparator | In the comparator group, patients will be undergo emergency surgery. Surgical options including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. Receives: Procedure: Emergency Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of primary colorectal anastomosis
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
Secondary outcomes (8)
Stoma rates
The stoma constructed for any reason, whether temporary or definitive.
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
Mortality
Death from any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 2 years
Procedure related complication
Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis, re-obstruction, stent migration, perforation, bleeding, etc.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rates
Re-operation is defined as repeat surgery or endoscopic treatment for whatever reason within 2 years.
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
R0 resection
R0 resection is defined as negative resection margins and no residual tumor.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
Quality of life
Quality of life assessments will be done with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire,EORTC QLQ-C30, and the questionnaire module for colorectal cancer, EORTC QLQ-CR29.
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
Hospital stay and cost
Measured: From date of the admission to discharge, assessed up to 30 days
Recurrence of colorectal cancer
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Malignant Colonic ObstructionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Side Liu, M.D., Study chair, Department of Gastroenterology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997684
- Sponsor's protocol ID
- ISR-ENDO-2013-001
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
PubMed 21398178Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
PubMed 21170659Ghazal AH, El-Shazly WG, Bessa SS, El-Riwini MT, Hussein AM. Colonic endolumenal stenting devices and elective surgery versus emergency subtotal/total colectomy in the management of malignant obstructed left colon carcinoma. J Gastrointest Surg. 2013 Jun;17(6):1123-9. doi: 10.1007/s11605-013-2152-2. Epub 2013 Jan 29.
PubMed 23358847Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.
PubMed 20026830Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.
PubMed 21559998
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Cohort Study
- ClinicalTrials.gov ID
- NCT01997684
- Acronym / sponsor ID
- ISR-ENDO-2013-001
- Keywords
- Colorectal Cancer, Colonic Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality.
However, the available body of literature addressing their benefit in this setting is contradictory.
The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
Detailed description
Colorectal cancer is one commonly diagnosed malignancy worldwide, with an estimated 10 million new cases and 6 million deaths . Around 8%-29% of patients with colorectal cancer present with acute colonic obstruction, and 70% of all malignant obstruction occurs in the left-sided colon. It has been reported that about 15%-20 % of patients with colorectal cancer present with acute obstructive symptoms at the time of diagnosis.
Conventionally, these patients are treated with emergency surgery to restore luminal continuity, which includes a variety of strategies such as the so-called two-stage surgery involving primary resection with colostomy (i.e., Hartmann's procedure) or proximal colostomy followed by resection, and one-stage surgery involving primary resection with anastomosis. Whatever the strategy chosen, the emergency surgery has an associated high risk of morbidity and mortality, and about two-thirds of such patients end up with a permanent stoma, which caused lower health-related quality of life and costs associated with stoma care.
Since 1991, the colonic stenting has been applied as palliative treatment for patients with unresectable colorectal cancer. In 1993, Tejero et al. reported using colonic stenting as a bridge to definitive surgery. Recently, Zhang et al. conducted a meta-analysis of 8 studies (6 retrospective and 2 randomized trials) and indicated that stent placement before elective surgery, also known as a bridge to surgery, lead to a reduction in need of intensive care (risk ratio [RR], 0.42; 95% confidence interval, 0.19-0.93), stoma creation (RR, 0.70; 0.50-0.99), and overall complications (RR, 0.42; 0.24-0.71) compared with the emergency surgery cohort, meanwhile, colonic stenting with elective surgery achieved higher primary anastomosis rate (RR, 1.62; 1.21-2.16), and did not adversely affect the mortality and long-term survival. The most common complications of colonic stenting were re-obstruction (12%), migration (11%), and perforation (4.5%).
However, the available body of literature addressing the benefit of colonic stenting with elective surgery is contradictory, and limited by the lack of the prospective randomised controlled trials. Therefore, we plan to conduct this multicenter, prospective, open label,cohort study, to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonic Stenting with Elective Surgery | Experimental | Procedure: Colonic Stenting with Elective SurgeryIn the experimental group, the patients will undergo colonic stenting within 24 h of inclusion. For this study, the WallFlex ™ Colonic Stent (Boston Scientific, Natick, MA) will be employed. Candidates for elective surgery, after clinical success of colonic stenting, will be preferably operated on 5-14 days after inclusion, and no later than 4 weeks. Type and extent of the elective surgery will be selected by the surgeon. In this group, unplanned emergency surgery will be indicated in case of technical failure of colonic stenting, iatrogenic morbidity, or clinical failure. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. |
| Emergency Surgery | Active comparator | Procedure: Emergency SurgeryIn the comparator group, patients will be undergo emergency surgery. Surgical options including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis. In case of a primary colostomy, restoration of bowel continuity was attempted within 3-6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years of age.
- Symptoms of colonic obstruction, existing less than one week.
- Malignant obstruction in the colon.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk.
- Patients with signs of peritonitis, perforation, sepsis, or other serious complications demanding emergency surgery.
- Patients with distal rectal cancer less than 8 cm from the anal verge.
- Patients with suspected or proven metastatic adenocarcinoma.
- Patients with unresectable colorectal cancer, or planning for palliative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic Stenting with Elective SurgeryAlso: Colonic stenting as a bridge to elective surgery, Colonic stenting and elective surgery, Colonic stenting and deferred surgery, Preoperative colonic stentingAfter preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed. If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery. Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks. Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis. | Procedure or surgery | Colonic Stenting with Elective Surgery |
| Emergency SurgeryType and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis. | Procedure or surgery | Emergency Surgery |
Primary outcome
Rates of primary colorectal anastomosis
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery.
8 secondary outcomes
Stoma rates
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 2 years
Procedure related complication
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rates
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
R0 resection
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Quality of life
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Hospital stay and cost
Time frame: From date of the admission to discharge, assessed up to 30 days
Recurrence of colorectal cancer
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Background: PubMed 21398178van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
- Background: PubMed 21170659Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
- Background: PubMed 23358847Ghazal AH, El-Shazly WG, Bessa SS, El-Riwini MT, Hussein AM. Colonic endolumenal stenting devices and elective surgery versus emergency subtotal/total colectomy in the management of malignant obstructed left colon carcinoma. J Gastrointest Surg. 2013 Jun;17(6):1123-9. doi: 10.1007/s11605-013-2152-2. Epub 2013 Jan 29.
- Background: PubMed 20026830Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.
- Background: PubMed 21559998Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S. Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg. 2011 Aug;35(8):1904-10. doi: 10.1007/s00268-011-1139-y.
- Homepage of Nanfang Hospital, Southern Medical UniversityLink provided by the sponsor.
- Homepage of Department of Gastroenterology, Nanfang Hospital, Southern Medical UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Side Liu, M.D. study chair
Department of Gastroenterology, Nanfang Hospital, Southern Medical University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonic Stenting with Elective Surgery and Emergency Surgery in people with Acute Malignant Colonic Obstruction and Colorectal Cancer, run by Nanfang Hospital, Southern Medical University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobing Cui, M.D. (+86 13631312723, xbing119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of primary colorectal anastomosis (time frame: From date of randomization until the first follow-up ended, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997684, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 2 Nov 2026.