Treatment of Thrombosed Haemorrhoids in Pregnancy

NCT04588467 | Completed DMC

• 1 other identifier: 6835447
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Thrombosis of the external hemorrhoids (TEH) is one of the most frequent complain during pregnancy, particularly during the third trimester. The paucity of the medical literature on this topic has recently been underlined in the European guidelines for hemorrhoid treatment . The aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of TEH in pregnant women

Conditions

Haemorrhoidal Crisis; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Pain evaluation: scale

  A scale of pain will be administered to patients

  10 days

• Quality of Life evaluation: questionnaire

  A questionnaire of quality of life will be administered to patients after the treatment

  10 days

Study Arms (2)

Conservative group

ACTIVE COMPARATOR

Conservative treatment included dietary modification (intake of at lest 3 liters of water), stool-softeners (a 25 ml solution containing: Macrogol 3350: 13.125 g Sodium chloride: 0.3508 g Sodium hydrogen carbonate: 0.1786 g Potassium chloride: 0.0502 g) and local anesthetics application (Lidocaine 2.5%+Prilocaine 2.5%, 2g twice a day) for 10 days

Other: Medical treatment

Surgical group

EXPERIMENTAL

Thrombectomy and local excision of external hemorrhoids were performed with the patient in the lithotomy position under local infiltrative anesthesia with UltracainDS 1:200000 1.7ml

Procedure: Surgical treatment

Interventions

Medical treatment OTHER

Pregnant women complaining thrombosed haemorrhoids will receive dietary modification (intake of at lest 3 liers of water), stool-softeners (a 25 ml solution containing: Macrogol 3350: 13.125 g Sodium chloride: 0.3508 g Sodium hydrogen carbonate: 0.1786 g Potassium chloride: 0.0502 g) and local anesthetics application

Conservative group

Surgical treatment PROCEDURE

Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia

Surgical group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy
• Thrombosed external haemorrhoids
• Written consent

You may not qualify if:

• Inflammatory bowel disease
• Cancer
• Age lower than 18 years old

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Clinic of Colorectal and Minimally invasive surgery

Moscow, 119435, Russia

Location

Related Publications (1)

• Medkova Y, Tulina I, Novikov I, Nikonov A, Ischenko A, Aleksandrov L, Altomare DF, Dezi A, Picciariello A, Tsarkov P. Thrombosed external hemorrhoids during pregnancy: surgery versus conservative treatment. Updates Surg. 2024 Apr;76(2):539-545. doi: 10.1007/s13304-023-01741-y. Epub 2023 Dec 27.

  PMID: 38151682 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Inna Tulina, Prof

  Russian Society of Colorectal Surgeons

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: January 2, 2019
• Primary Completion: March 2, 2020
• Study Completion: October 2, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)