Study of MIRUSâ?¢ Disposable Hemorrhoids Stapler used in surgery during the treatment of prolapsed Hemorrhoids (Piles) to evaluate safety and efficacy of the device in post marketing period.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2017/05/008476
- Lead Sponsor
- Meril Endo Surgery Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. Male and female subjects who are 18 to 80 years of age.
2. Those subjects with late grade II hemorrhoids and unlikely to respond to one or two sessions of rubber band ligation (RBL) and/or conservative treatment.
OR
3. Subjects with grade III (prolapsing internal hemorrhoids requiring manual reduction) and/or grade IV (irreducible prolapse) are suitable candidate with stapled hemorrhoidopexy.
4. Subject must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
5. Subject must follow the post-operative follow-up visits for 6 months.
Any potential subject who meets any of the following criteria will be excluded from participating in the study:
1. Any female subject, who is pregnant, suspected pregnancy at the time of screening.
2. Subjectâ??s tissue thickness found to be less than 0.75mm or greater then 1.5mm, or where the internal diameter of the rectum will not be able to accommodate the instrument and
accessories.
3. Subjectâ??s tissue has undergone multiple injections of hardening agent at hemorrhoids.
4. The subject has a history of fecal incontinence.
5. The subject has an active or a history of infection requiring antibiotics at the intended operative site within 30 days prior to the planned surgery date.
6. The subject has a history of venous thrombosis or pulmonary embolism.
7. The subject has a history of coagulopathy.
8. The subject has taken aspirin, anti coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
9. The subject has existing anal stenosis/severe mucosal edema or any other co-morbidities which in the opinion of the investigator will not be appropriate for the study.
10. Subject undergone multiple injections in tissue, using hardening agents or with history of acutely prolapsed thrombosed piles associated anal fistulas (abnormal connection between anal canal & skin), anal fissures (anal
ulcer), abscess (pus under the skin surrounding the anus) or rectal prolapse.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Immediate postoperative complications and short term outcomes related to study device. <br/ ><br>- Number of AE/SAE related to study device during 6 month of study period. <br/ ><br>- Post Operative PainTimepoint: At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
- Secondary Outcome Measures
Name Time Method 1. Incidence of Stapler Malfunction or Misfires <br/ ><br>2. Operation Time <br/ ><br>3. Length of Hospital Stay <br/ ><br>4. Reapparition of the hemorroidal symptoms and/or <br/ ><br>Reoperations <br/ ><br>5. Standardized Stapled Hemmorrhoidectomy Quality Of <br/ ><br>Life (QOL) <br/ ><br>6. Overall Quality of LifeTimepoint: At baseline, About 20 minutes for procedure, Day 0, time of discharge minus time of admission , 15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)