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Trial · Interventional

CompletedPhase 4Registry data

The Effect of Octreotide on Wound Drainage After Mastectomy

NCTNCT05682209 (opens ClinicalTrials.gov in a new tab)Other idUI/EC/20/0275
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
41 participants (actual)
Sponsor
Ikechukwu Bartholomew Ulasi · Other
Design
Randomized · Triple masking
Countries
1 country

Nigeria

Start
18 Dec 2020
Primary completion
15 Nov 2021
Completion
2 Dec 2021
First posted
12 Jan 2023
Last update posted
18 Jan 2023
Conditions
Seroma Following Procedure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 4

    The Effect of Octreotide on Wound Drainage After Mastectomy

    NCT05682209

    18 Dec 2020 to 2 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients who had mastectomy for breast cancer usually have drainage of some fluid from the site of surgery. This could be prolonged and may lead to other negative consequences after surgery. Octreotide could potentially reduce the amount of this drainage. In this study, patients were grouped into two: a first group that received octreotide injection and a second group that received a placebo. The study tested whether octreotide injection has any effect on the duration of fluid drainage from the surgery site after mastectomy for breast cancer.

Interventions

  • Octreotide InjectionDrug
  • Sterile waterOther

Arms2

  • Active comparator

    Octreotide group

    Received 100µg of octreotide intravenously 8-hourly for 5 days from the first post-operative day

  • Placebo comparator

    Control group

    Received 1ml of sterile water intravenously 8-hourly for 5 days from the first post-operative day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to drain removal

    Time frame · 24 hours after surgery till a drain output of <40ml in the preceding 24hours

    Registry description

    Time that elapsed from the day of surgery till the wound drain was removed

Secondary outcomes(1)

  1. Incidence of seroma

    Time frame · From the first post-operative day till 28 days post-operatively

    Registry description

    Clinically evident serous fluid collection at the operation site

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2003

4 results

Octreotide in the treatment of lymphorrhea after axillary node dissection: a prospective randomized controlled trial.

Carcoforo et al. 2003Journal of the American College of Surgeonscited by 50

PMID 12648685DOI 10.1016/s1072-7515(02)01757-xPUB-12648685

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * All female breast cancer patients requiring modified radical mastectomy Exclusion Criteria: * All mastectomies without axillary clearance (simple and toilet mastectomies) * Breast-conserving surgeries * Patients undergoing immediate breast reconstruction after mastectomy * Previous axillary surgery

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