TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
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ClinicalTrials.gov Identifier: NCT02295592 |
Recruitment Status : Unknown
Verified October 2014 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was: Not yet recruiting
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
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Condition or disease | Intervention/treatment | Phase |
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Hemorrhoids | Procedure: TSTstarr+ Procedure: PPH | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 780 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | April 2016 |
Estimated Study Completion Date : | October 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: group A( TSTstarr+ group)
TSTstarr+ is a kind of modified STARR(stapled transanal rectal resection ) operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation .
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Procedure: TSTstarr+
TSTstarr+ : a kind of modified STARR(stapled transanal rectal resection ) operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation . |
Active Comparator: group B ( PPH group)
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
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Procedure: PPH
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. |
- the recurrence rate of the severe prolapsed Hemorrhoids after surgery [ Time Frame: 2 years ]780 patients will be enrolled in one year.All patients will be followed up for one year, and then calculate 1 year recurrence rate between TSTstarr+ group and PPH group
- Operation time [ Time Frame: 1 year ]
- Intraoperative hemorrhage [ Time Frame: 1 year ]
- The weight of specimens [ Time Frame: 1year ]
- The volume of specimens [ Time Frame: 1year ]
- The number of patients with anal pain after surgery [ Time Frame: 2 years ]
- The number of patients with fecal urgency after surgery [ Time Frame: 2 years ]
- The number of patients with stricture of anus after surgery [ Time Frame: 2 years ]
- The number of patients with hemorrhage after surgery [ Time Frame: 2 years ]
- The number of patients with retention of urine in the early time after surgery [ Time Frame: 2 years ]
- The number of patients with edema of the anal margin in the early time after surgery [ Time Frame: 2 years ]
- The time of returning to normal [ Time Frame: 2 years ]
- The total cost of hospitalization [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- severe prolapsed hemorrhoids
- no significant anal-malformation before operation
- having signed the informed consent.
Exclusion Criteria:
- needing emergency operation or having previous history of hemorrhoids operation
- with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on
- diagnosed with inflammatory bowel disease or proctitis
- diagnosed with colorectal cancer
- associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery
- with chronic or acute renal insufficiency patients
- coagulation abnormalities or with anticoagulation treatment at present
- diagnosed with diabetes with poor glycemic control
- in women with pregnant or menstruation
- The intellectual disabilities or mental disorder
- had participated in other clinical trial before we selected 4 weeks
- other severe complications.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295592
Contact: Lin Hongcheng, Medicine Doctor | +86 159158157 76 | linhongcheng@hotmail.com |
Responsible Party: | Sixth Affiliated Hospital, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02295592 |
Other Study ID Numbers: |
2014ZSLYEC-021 |
First Posted: | November 20, 2014 Key Record Dates |
Last Update Posted: | November 20, 2014 |
Last Verified: | October 2014 |
hemorrhoids The recurrence rate PPH TSTstarr+ |
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |