Trial Outcomes & Findings for A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection (NCT NCT02476357)

NCT ID: NCT02476357

Last Updated: 2020-08-06

Results Overview

Duration (days) between surgery and removal of postoperative suction drain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days
• Results posted on: 2020-08-06

Participant Flow

Participant milestones

Measure	Harmonic Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) Harmonic scalpel	Control Monopolar scalpel and ligature Harmonic scalpel
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Harmonic n=40 Participants Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)	Control n=40 Participants Monopolar scalpel and ligature	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=40 Participants	15 Participants n=40 Participants	31 Participants n=80 Participants
Age, Categorical >=65 years	24 Participants n=40 Participants	25 Participants n=40 Participants	49 Participants n=80 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 15.1 • n=40 Participants	61.9 years STANDARD_DEVIATION 13.3 • n=40 Participants	60.8 years STANDARD_DEVIATION 14.1 • n=80 Participants
Sex: Female, Male Female	24 Participants n=40 Participants	24 Participants n=40 Participants	48 Participants n=80 Participants
Sex: Female, Male Male	16 Participants n=40 Participants	16 Participants n=40 Participants	32 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants

PRIMARY outcome

Timeframe: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days

Duration (days) between surgery and removal of postoperative suction drain

Outcome measures

Measure	Harmonic n=40 Participants Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)	Control n=40 Participants Monopolar scalpel and ligature
Postoperative Draining Time	31 days Standard Deviation 20	32 days Standard Deviation 18

SECONDARY outcome

Timeframe: Lymph quantity measured every day, up to 50 days.

Population: One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home

Patients had to record on a list the amount in ml. of lymph in the suction drain bottles

Outcome measures

Measure	Harmonic n=39 Participants Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)	Control n=40 Participants Monopolar scalpel and ligature
Daily Amount of Drained Lymph	2908 ml. Standard Deviation 2453	3898 ml. Standard Deviation 5791

Adverse Events

Harmonic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr Med. Maurice MATTER

Lausanne University Hospita! and University of Lausanne

Phone: 795561071

Email: maurice.matter@chuv.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place