Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study

Yun Hwan Kim; Hyun Joo Shin; Woong Ju; Seung-Cheol Kim

doi:10.3802/jgo.2017.28.e37

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Kim, Shin, Ju, and Kim: Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study

Original Article

J Gynecol Oncol 2017;28(3):e37.

Published online: 4 May 2017

DOI: https://doi.org/10.3802/jgo.2017.28.e37

Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study

Yun Hwan Kim, Hyun Joo Shin, Woong Ju, Seung-Cheol Kim

Department of Obstetrics and Gynecology, Ewha Womans University School of Medicine, Seoul, Korea

Correspondence to Yun Hwan Kim Department of Obstetrics and Gynecology, Ewha Womans University School of Medicine, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Korea. E-mail: kimyhmd@ewha.ac.kr

Received 12 November 2016 Revised 22 January 2017 Accepted 8 February 2017

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective

This prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy.

Methods

Each patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product application being the control side. The amount of lymph drainage at each side of the pelvis was measured for 3 days, and computed tomography scans were obtained 7 days and 6 months after surgery for detection of pelvic lymphocele.

Results

Among 37 cases, the median amount of lymph drainage was significantly decreased in the hemi-pelvis treated with FloSeal compared to the control hemi-pelvis (p=0.025). The occurrence of lymphocele was considerably reduced in treated hemi-pelvis (8/37, 21.6%) compared with control hemi-pelvis (12/37, 32.4%) after 7 post-operative days (p=0.219), and more decreased in the treated hemi-pelvis (5/37, 13.5%) compared with control hemi-pelvis (9/37, 24.3%) after postoperative 6 months (p=0.344).

Conclusion

The application of FloSeal as a tissue sealant in lymph nodes resected tissues can reduce the incidence of pelvic lymphocele in gynecologic cancer patients. A large randomized controlled study could confirm these preliminary results.

Keywords: Genital Neoplasms, Female, Lymphocele, Drainage, Secondary Prevention, Lymph Node Excision, Surgical Oncology

References

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Fig. 1.

Flow chart of participating patients presented by the Consolidated Standards of Reporting Trials diagram.

Table 1.

Patients characteristics between the 2 groups according to the site of FloSeal application (n=37)

Characteristics	Right side (n=19)	Left side (n=18)	p-value
Age	52 (34–70)	52 (27–67)	0.915^*
Type of tumor			0.980^†
Cervical cancer	5 (26.3)	5 (27.8)
Endometrial cancer	6 (31.6)	6 (33.3)
Ovarian cancer	8 (42.1)	7 (38.9)
Adjuvant irradiation	4 (21.1)	5 (27.8)	0.634^†
Concurrent PALN dissection	19 (100.0)	16 (88.9)	0.230^†
No. of PLN	19 (6–35)	19 (5–42)	0.456^*
No. of PALN	6 (1–20)	6 (1–25)	0.336^*
Blood loss (mL)	700 (50–4,000)	500 (150–1,600)	0.461^*

Values are presented as median (range) or number (%). PALN, para-aortic lymph node; PLN, pelvic lymph node.

^* Mann-Whitney U test;

^† Chi-square test.

Table 2.

Total amount of 3-day pelvic lymph drainage and incidence of lymphocele at each hemi-pelvis at 7 days and 6 months postoperative

Characteristics	Control hemi-pelvis (n=37)	Study hemi-pelvis (n=37)	p-value
Amount of lymph drainage, mL	620 (102–1,390)	400 (88–1,320)	0.025^*
Lymphocele at post-operative
1 wk	12 (32.4)	8 (21.6)	0.219^†
6 mo	9 (24.3)	5 (13.5)	0.344^†

Values are presented as median (range) or number (%).

^* Wilcoxon signed-rank test;

^† McNemar test.

Table 3.

Distribution and size of pelvic lymphocele at 6 months after operation

Location	Control hemi-pelvis (n=37)	Study hemi-pelvis (n=37)
External iliac	9 (2; 1–4)	4 (2; 1.0–2.5)
Internal iliac	0	0
Common iliac	0	1 (4; 4–4)

Values are presented as number (median diameter; range, cm).

Table 4.

Preventive methods against lymphocele after pelvic lymphadenectomy in gynecologic malignancies

Preventive methods	Study design	No. of patients	Lymphocele	Symptomatic lymphocele
Peritoneum no-closure [5]	RCT	31 closure vs. 30 no-closure	16/31 (51.6) vs. 7/30 (23.3); p<0.050	11/31 (35.5) vs. 4/30 (13.3); p<0.100
No drain [6]	RCT	68 drain vs. 69 no-drain	NA	16/68 (23.5) vs. 9/69 (13.0); p=0.007
Omentoplasty [4]	Pilot study	10 none vs. 12 omentoplasty	0/10 (0.0) vs. 0/12 (0.0)	0/10 (0.0) vs. 0/12 (0.0)
Vaginal stump open [7]	Retrospective	79 closure vs. 101 stump open	12/79 (15.2) vs. 6/101 (5.9); p<0.050	NA
Ultrasonic shear [8]	Prospective	100 cases	0/100 (0.0)	NA
Surgical clip [9]	RCT	30 bipolar energy vs. 30 clipping	9/30 (30.0) vs. 1/30 (3.3); p=0.006	2/30 (6.6) vs. 0/30 (0.0); p=0.240
Fibrin glue [10]	RCT	46 none vs. 47 fibrin glue	21/46 (46.0) vs. 20/47 (43.0); p=0.763	4/46 (8.7) vs. 3/47 (6.4); p=0.901
Collagen-fibrin patch [11]	RCT (pilot)	28 none vs. 30 collagen-fibrin patch	16/28 (57.1) vs. 7/30 (23.3); p=0.015	9/28 (32.1) vs. 3/30 (10.0); p=0.053

Values are presented as number (%). NA, not available; RCT, randomized controlled trial.

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