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A comparison of two methods of physiotherapy for treating lower limb lymphedema following treatment for women with genital organ cancers

Prospective randomized controlled study comparing the efficacy of manual lymphatic drainage and pneumatic compression therapy on secondary lower limb lymphedema in patients undergoing surgery and/or radiotherapy for gynaecological malignancies.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030940
Enrollment
140
Registered
2021-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C53- Malignant neoplasm of cervix uteri Health Condition 2: C541- Malignant neoplasm of endometrium Health Condition 3: C56- Malignant neoplasm of ovary Health Condition 4: C51- Malignant neoplasm of vulva

Interventions

Intervention1: Pneumatic compression therapy: The Pneumatic Compression Therapy (PCT) consists of a pump that applies pressure to multiple individual chambers inside the garment (Lympha press optimal)

Sponsors

Sri Venkateswara Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing female subjects with biopsy proven gynaecological malignancies (Carcinoma of endometrium, Carcinoma of cervix, Carcinoma of ovary and Carcinoma of vulva) undergoing curative surgery and or radiotherapy at SVIMS, Tirupati will be included for the estimation of incidence of lymphedema. Of these women who develop lymphedema will be included 2. Age between 30-65 years 3. Grade â?? 1 to 3 lymphedema (Annexure 2)

Exclusion criteria

Exclusion criteria: 1.Patients who are not willing to participate in the study 2.Age below 30 and above 65 years 3.Primary lymphedema or secondary lymphedema of different etiology at the time of diagnosis 4.Patients with past history of treatment for any cancer including gynaecological cancer, metastatic cancer, unilateral or bilateral amputation. 5.Grade â?? 4 lymphedema excluded. 6.Patients who are undergoing surgery for gynaecological malignancies without pelvic lymph node resection. 7.Patients who have had prior lower extremity vascular surgery. 8.Patients with past history of chronic lower limb swelling.

Design outcomes

Primary

MeasureTime frame
1 incidence of lymphedema in post gynaecological malignencies 2. Limb circumference measurement in centimetres Timepoint: 3 years

Secondary

MeasureTime frame
.VAS score in units 6. Quality of life score as per the questionnaire Timepoint: 3 years

Countries

India

Contacts

Public ContactRaghav Krishna S

Sri Venkateswar Institute of Medical Sciences

raghavasvims@gmail.com9885385150

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026