Salpingo(s)tomy versus salpingectomy for tubal pregnancy; impact on future fertility

Transcription

1 Patient registration label Salpingo(s)tomy versus salpingectomy for tubal pregnancy; impact on future fertility CASE RECORD FORM Patient Identification Number European Surgery in Ectopic Pregnancy study group

2 /7 Contents Case Record Form General information 2 Flowchart: inclusion and exclusion criteria 3 Part A: Check 4 Part B: Patient characteristics 5 Part C: Risk factors 6 Part D: TVS and serum hcg-measurement 8 Part E: Start surgery 9 Part F: Randomisation Part G: Treatment Part H: Follow-up 3 Appendix : serum hcg clearance curve for the diagsis of persistent trophoblast after salpingo(s)tomy 5 Appendix 2: Recommendations for laparoscopic salpingo(s)tomy for tubal pregnancy 6

3 2/7 General information A correct answer is given by crossing a box. In case of an incorrect answer blackening of the box and cross the correct answer together with date and your initials. No abbreviations in text box items. In case of an incorrect answer, do t cross out. Put the correct answer next to it together with date and your initials. If the patient is excluded during surgery, complete this Case Record Form until part F, keep it in the study box. Do t start the randomisation program. A conversion from salpingo(s)tomy to salpingectomy is t a protocol violation, the study can be continued. Appendix : To detect persistent trophoblast, follow your local protocol. A serum hcg clearance curve after salpingo(s)tomy and recommendations for treatment of persistent trophoblast are presented. Appendix 2: Recommendations for laparoscopic salpingo(s)tomy for tubal pregnancy. Additional techniques are allowed, please register in the Case Record Form (question 27, page ). The European Surgery in Ectopic Pregnancy Group will follow-up all patients to assess fertility after surgery for tubal pregnancy. In case of any difficulties, remarks or questions, please contact Mrs F. Mol, MD, esep@amc.uva.nl or Mrs P.J. Hajenius, MD, PhD, p.hajenius@amc.uva.nl Academic Medical Center, University of Amsterdam Department of Obstetrics and Gynaecology (H4-25) PO Box 227 DE Amsterdam, The Netherlands phone fax: Thank you for your cooperation, European Surgery in Ectopic Pregnancy study group

4 3/7 Flowchart Inclusion: clinical suspicion of tubal pregnancy (age 8 yrs) scheduled for surgery Informed consent Exclusion before surgery Signs of shock Pregnant after IVF-ET Kwn bilateral tubal factor, by previous HSG or laparoscopy Previous salpingectomy No Log Registration Surgery Randomisation Exclusion during surgery No tubal pregnancy Salpingo(s)tomy t possible Severe damage of contra lateral tube (hydrosalpinx, peri tubal adhesions or malformations interfering with pregnancy) Salpingo(s)tomy Pre-operative serum hcg Laparoscopy/laparotomy Conversion to salpingectomy Complications Persistent trophoblast? Salpingectomy Pre-operative serum hcg Laparoscopy/ laparotomy Complications Persistent trophoblast? Follow-up 6, 2, 8, 24, 3, 36 months after index tubal pregnancy Desire future pregnancy Spontaus intra uterine pregnancy Repeat ectopic pregnancy Registration in CRF

5 A. Check flow-chart Date of Birth 4/7 Patient meets inclusion criterion: clinical suspicion of tubal pregnancy, age 8 yrs Patient does t meet exclusion criteria before surgery Patient gives informed consent Add Informed Consent Form to CRF Check patients address and phone number on front page Fill in part B, C and D

6 5/7 B. Patient characteristics. Date of first contact 2. Para + miscarriage (AD < 6 wks) (n) (n) induced abortion ectopic pregnancy molar pregnancy 3. First day of LMP (if unkwn, fill in ) 4. Symptom: vaginal bleeding 5. Symptom: abdominal pain

7 6/7 C. Risk factors 6. History of asymptomatic Chlamydia infection? 9 unkwn 7. History of Pelvic Inflammatory Disease? 9 unkwn 8. History of ectopic pregnancy? 9 unkwn Site Treatment year left right n-tubal unkwn salpingo(s)tomy salpingectomy MTX expectant unkwn management Please specify. Exclusion RCT, registration

8 7/7 9. Kwn tubal pathology (HSG, laparoscopy, tubal surgery)? 2 left 3 left and right Exclusion RCT, registration 9 unkwn 4 right 8 site unkwn. DES-exposure? 8. 9 unkwn. IUD in situ? 9 unkwn

9 D. TVS and serum hcg-measurement 2. Ectopic mass? 8/7, specify diameter mm 3. Ectopic ring? 3. Embryo?, specify CRL mm 4. Fetal heartbeat? 5. Pre-operative serum hcg level hcg hcg hcg IU/L IU/L IU/L One value pre-operative is necessary. If t taken, please do so. Determine Rhesus factor. Part A through D filled in by. Signature.

10 9/7 E. Start surgery 6. Date of surgery 7. Start of surgery by laparoscopy 2 laparotomy 8. Tubal pregnancy identified? 2 tubal abortion 3 interstitial pregnancy exclusion ovarian pregnancy abdominal pregnancy unkwn 9. Salpingo(s)tomy possible? please specify: exclusion 2. Severe damage of contra lateral tube? 2 hydrosalpinx exclusion 3 4 severe peri tubal adhesions other, please specify: Continue study, start randomisation Exclusion: put CRF in study box

11 /7 F. Randomisation Start randomisation program via inlog venlo, password Venlo or via www. Select center Venlo, enter password: venlo Enter (Patient Identification Number) Fill in initials of the patient (first name, maiden name) and date of birth (yyyy-mm-dd) Answer question about tubal pathology based on history (previous ectopic pregnancy, previous tubal surgery, previous PID, tubal pathology documented by HSG or laparoscopy) 2. Result of randomisation: 2 Salpingo(s)tomy Salpingectomy

12 /7 G. Treatment 22. Site of tubal pregnancy 2 left right 23. Location of tubal pregnancy 2 3 isthmus ampulla fimbriae 24. Size of tubal swelling (pregnancy + hematoma) x x mm (3 directions in mm) 25. Conversion laparoscopy to laparotomy? this is t a protocol violation, continue study please specify: 8 t applicable (first entrée by laparotomy) 26. If salpingo(s)tomy, conversion to salpingectomy? this is t a protocol violation, continue study please specify: 8 t applicable (salpingectomy)

13 27. Complications during surgery? 2/7 2 intestinal lesion 5 complication of anesthesia 3 bladder lesion 6 other, please specify 4 vessel injury 28. Additional techniques used? Multiple answers possible vasopressin (POR8, glypressin) 2 Tissuecoll other Please specify: 29. Additional procedures performed? For example: adhesiolysis, ovariectomy, cystectomy, appendectomy Please specify: 3. Total blood loss ml 3. Time start anesthesia : : Time end anesthesia : Part E, F and G filled in by. Signature Please take care of the following: Send patients date of birth and initials and date of surgery to esep@amc.uva.nl Put CRF in patients record Take care of serum hcg follow-up, weekly measurements in both groups (See also appendix 2 in this CRF, serum hcg clearance curve after successful salpingo(s)tomy and diagsis of persistent trophoblast).

14 3/7 H. Follow-up 32. Blood transfusion?, units 33. Post-operative complications other than persistent trophoblast? 2 bleeding 3 infection 4 surgical re-intervention: please specify intervention: 5 other, please specify: 34. Hospital discharge 35. Re-admittance to in-patient clinic necessary? please specify: 36. Date of re-admittance 8 t applicable Date of second discharge 8 t applicable

15 4/7 37. Persistent trophoblast? (see also appendix ) date serum hcg undetectable, medically treated start systemic MTX - - d d m m d d y y m m y y dose (quantity) mg number of doses folinic acid mg (if t given, fill ) number of doses (if t given, fill ) 2, surgically treated date of surgery please specify intervention: 38. Date serum hcg undetectable after treatment for persistent trophoblast if t kwn, fill in Lost to follow up serum hcg? last measurement serum hcg level IU/L Part H filled in by:..signature. Please send us CRF, copy of letter of discharge, surgery report, pathology report. Thank you for your cooperation. For questions or remarks, please contact us esep@amc.uva.nl European Surgery in Ectopic Pregnancy study group Mrs P.J. Hajenius, MD, PhD Department of Obstetrics and Gynaecology H4-25 Academic Medical Center, University of Amsterdam Meibergdreef 9, PO box 227 DD Amsterdam, The Netherlands

16 5/7 Appendix : Serum hcg clearance curve for the diagsis of persistent trophoblast after salpingo(s)tomy (Ref: P.J. Hajenius et al Human Reprod 995; : 683-7) 9 serum hcg (% of intial value) days post operative Persistent trophoblast is defined as rising or plateauing serum hcg concentrations post operatively Measurement Preferably take serum hcg samples post-operatively, and 2 weeks after salpi(s)tomy Treatment Persistent trophoblast is usually treated with systemic Methotrexate (mg/kg) im either in a single dose regimen or in a multiple dose regimen (day,2,4,6) in combination with folinic acid. mg/kg orally (day,3 5,7).

17 6/7 Appendix 2: Recommendations for laparoscopic salpingo(s)tomy for tubal pregnancy. Any blood vessels over the bulging ectopic mass at the intended incision site are first coagulated before the fallopian tube is being incised. The conceptus immediately protrudes through the incision and is grasped with an atraumatic, or spoon forceps and is gently extracted. Hydrodissection may be helpful in creating a cleavage plane between the tubal pregnancy and the surrounding tissue. Care must be taken to remove the actual trophoblast, t just blood clots. As a rule, the trophoblastic tissue can be found at the uterine site of the bulging portion of the tube. In contrast to the dark red hematoma, trophoblastic tissue shows a whitish-pink color. It is usually possible to remove the trophoblastic tissue completely. The tube is then irrigated through the wound with saline or Ringer s solution, and any persistent bleeding sites are coagulated meticulously. The incision is left open to heal by secondary intention. The use of glue in closing the incision of the fallopian tube is t recommended. The use of vasopressin or glypressin to infiltrate the mesosalpinx to reduce bleeding, is left at the discretion of the surgeon and should be registered in the Case Record Form (question 28, page 2).