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The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.
This is a single-center prospective randomized controlled study will be conducted on the basis of the surgical department. Patients with symptomatic hemorrhoids and who will be intended for surgical treatment (open hemorrhoidectomy) will be randomly allocated to one of the group. Prior to surgery the demographic and clinical data will be collected. Open hemorrhoidectomy under spinal anesthesia will be performed with one of the technical options according to the patient's group:
Intraoperative and postoperative data will be collected during first week after surgery and 30 days after surgery. Then the primary and secondary outcomes are evaluated between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpel | Active Comparator | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose. |
|
| Open hemorrhoidectomy with electrosurgical scalpel | Active Comparator | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open hemorrhoidectomy with 'cold' scalpel | Procedure | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest and during defecation | The pain was assessed using a visual analogue scale (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end) | during 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of prescribing opioid analgesics | the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end) | 3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Garmanova, PhD | Contact | +79773429249 | tatianagarmanova@gmail.com | |
| Ekaterina Kazachenko, MD | Contact | +79269721922 | ekaterina.k.97@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University | Moscow | 119991 | Russia |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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In case of meeting inclusion criteria of patient the selection of the group will be determined by randomization, so both groups will be recruited simultaneously
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Before the operation, all patients are scheduled to perform an open hemorrhoidectomy, which includes radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Patients are not informed about which instrument will be used.
All collected information will be stored in electronic databases, where patient names and group numbers are anonymized and encrypted. Thus, during the statistical calculation, a person will not know about the name of the group.
|
| Open hemorrhoidectomy with electrosurgical scalpel | Procedure | Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding. |
|
| Other medications use |
The frequency of other analgesics taken |
| 10 days after surgery |
| Readmission rate | The number of cases of repeated appeals for relapse of the disease or hospitalizations | 30 days after surgery |
| The life quality rate | The overall quality of life was assessed using the EQ-5D patient questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. | 7 and 30 days |
| Complication rate | Cases of bleeding, urinary retention, infectious complications after surgery | within 30 days after surgery |
| Residual symptoms | The presence of residual symptoms after surgery | 30 days after surgery |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |